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Type: Pharmaceutical Intermediates
Place of Origin: China (Mainland)
CAS No.: 1318-93-0

Specifications

Diosmectite (Dioctahedral Smectite) for pharmaceutical use:

Diosmectite (Dioctahedral smectite )  is a great product that our company select from high quality bentonite, and adopts advanced technology to manufacture, and use the advanced craft, refined it after purify highly according to the medicine standard.

Product Application

Widely used as an anti-diarrhoeal pharmaceutical raw material for chronic or acute diarrhea in adults or children. 

Mechanism of Action:

 1.Immobilize and Eliminate viruses, germs and toxins produced inside the alimentary canal;
 2.Protects the mucosa from pathogen insult;
 3.Facilitates mucosa repair and regeneration;

 4.Balances the enteric flora and promotes homeostasis and blood clotting.

Test ReportDiosmectiteMontmorillonitefor Pharmaceutical use
Test Item
Standard
Acidity and alkality
Not more intense than white precipitate produced by 5.0 ml of standard sodium chloride solution.
Carbonate
Negative
Water-solute Matter
No more than 0.7%
Loss on Drying
Loss wt. not more than 10.0%
Particle size
d(0.5)6-23μm;
d(0.9)16-50μm;
Volume average particle size D[4,3]8-27μm
Heavy Metals
Not more than 10 ppm
Arsenic
Not more than 2 ppm
Swelling Capacity
2.0-5.0
Absorbability
Strychnine Sulfate adsorbed per gram should be 0.35to 0.55g
Christobalite and other impurities test
In the obtained sample X-ray diffraction spectrum, peak height ratio of christobalite should be ≤50%, any other impurity ≤70%.
Total Bacterial Count
≤200 cfu/g
Mold
≤100 cfu/g
Escherichiacoli
None
E.Coliform
≤100 cfu/g
Assay(on dried basis)
The assay of Al2O3 should be 12.0%-25.0%
 
The assay of SiO2 should be 55.0%-65.0%